Gynecological Pelvic Floor Muscle Training

NCT ID: NCT01811602

Last Updated: 2015-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-08-31

Brief Summary

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A randomized controlled trial pilot study to test the efficacy of a pelvic muscular training intervention led by a physiotherapist on urinary incontinence, quality of life and sexual health in women who report urinary urgency and incontinence following surgery and radiation treatment for gynecological cancer vs. usual care (a 1-page sheet on Kegel exercises).

Detailed Description

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Training

Pelvic floor muscle training delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction

Group Type OTHER

Training

Intervention Type OTHER

The participants randomized to the pelvic floor muscle training intervention will receive pelvic floor muscle training (0-12 weeks) delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction. The intervention is 9 individual, one-on-one, 45-minute sessions; weekly for weeks 0-6 and bi-weekly for weeks 7-12 (first session will be 60 minutes). The sessions will provide pelvic floor muscle training based on the latest evidence, including biofeedback, to teach the correct technique for pelvic floor contractions, and participants will be asked to complete daily pelvic floor exercises at home.

Usual Care Control

Participants randomized to this arm will receive a 1-page educational pamphlet on pelvic floor muscle training, specifically Kegel exercises, which is equivalent to current standard care. Individuals randomized to this group will be placed on the clinic waiting list and be eligible for treatment following completion of the 12 week (end of study) measures.

Group Type OTHER

Usual Care

Intervention Type OTHER

The participants randomized to the educational pamphlet intervention (usual care control) will receive a 1-page sheet on pelvic floor muscle training, specifically Kegel exercises, which is equivalent to current standard care. Individuals randomized to this group will be placed on the clinic waiting list and be eligible for treatment following completion of the 12 week (end of study) measures.

Interventions

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Training

The participants randomized to the pelvic floor muscle training intervention will receive pelvic floor muscle training (0-12 weeks) delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction. The intervention is 9 individual, one-on-one, 45-minute sessions; weekly for weeks 0-6 and bi-weekly for weeks 7-12 (first session will be 60 minutes). The sessions will provide pelvic floor muscle training based on the latest evidence, including biofeedback, to teach the correct technique for pelvic floor contractions, and participants will be asked to complete daily pelvic floor exercises at home.

Intervention Type OTHER

Usual Care

The participants randomized to the educational pamphlet intervention (usual care control) will receive a 1-page sheet on pelvic floor muscle training, specifically Kegel exercises, which is equivalent to current standard care. Individuals randomized to this group will be placed on the clinic waiting list and be eligible for treatment following completion of the 12 week (end of study) measures.

Intervention Type OTHER

Other Intervention Names

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Pelvic Floor Muscle Training Educational pamphlet

Eligibility Criteria

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Inclusion Criteria

\- treated with surgery and adjuvant treatment, including radiation, for gynecological cancer within the last 3 years

Exclusion Criteria

* stage IV cancer or stage III and IV cervical cancer
* radiation not part of treatment
* known spinal or long bone metastases diagnosis with a neuromuscular disorder that may impact pelvic floor muscle function
* urinary incontinence issues prior to cancer diagnosis
* scheduled or previous surgical treatment of incontinence
* fecal incontinence
* body mass index (BMI) \> 35
* use of medications to improve bladder function
* unable to complete questionnaires in English or unable to actively participate in physiotherapy treatment provided in English.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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British Columbia Cancer Agency

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristin Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Women's Health Centre

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Kristin Campbell, PhD

Role: CONTACT

604-827-4704

Sarah Finlayson

Role: CONTACT

604-877-6000 ext. 2367

Facility Contacts

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Pat Lieblich, PT

Role: primary

Other Identifiers

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F12-00262

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H12-02473

Identifier Type: -

Identifier Source: org_study_id

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